Abstract
BackgroundWhen applying secondary analysis on published survival data, it is critical to obtain each patient’s raw data, because the individual patient data (IPD) approach has been considered as the gold standard of data analysis. However, researchers often lack access to the IPD. We aim to propose a straightforward and robust approach to help researchers to obtain IPD from published survival curves with a friendly software platform. ResultsImproving upon the existing methods, we proposed an easy-to-use, two-stage approach to reconstruct IPD from published Kaplan-Meier (K-M) curves. Stage 1 extracts raw data coordinates and Stage 2 reconstructs IPD using the proposed method. To facilitate the use of the proposed method, we develop the R package IPDfromKM and an accompanied web-based Shiny application. Both the R package and Shiny application can be used to extract raw data coordinates from published K-M curves, reconstruct IPD from data coordinates extracted, visualize the reconstructed IPD, assess the accuracy of the reconstruction, and perform secondary analysis on the IPD. We illustrate the use of the R package and the Shiny application with K-M curves from published studies. Extensive simulations and real world data applications demonstrate that the proposed method has high accuracy and great reliability in estimating the number of events, number of patients at risk, survival probabilities, median survival times, as well as hazard ratios. ConclusionsIPDfromKM has great flexibility and accuracy to reconstruct IPD from published K-M curves with different shapes. We believe that the R package and the Shiny application will greatly facilitate the potential use of quality IPD data and advance the use of secondary data to make informed decision in medical research.